Study of Acute Uncomplicated Seasonal Influenza A in Adult Subjects

Browse trials for

• Influenza, Human 2,214

Keywords

• Influenza A

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 292 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Eligibility criteria

Study arms

• Placebo comparator
  VX-787 Placebo BID + Oseltamivir Placebo BID

  Subjects will receive 10 doses of matching placebo of VX-787 and Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days.

  Drug: Placebo

• Active comparator
  VX-787 300 mg BID + Oseltamivir Placebo BID

  Subjects will receive 10 doses of VX-787 300 milligram (mg) tablet along with matching placebo of Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days.

  Drug: VX-787 300 mg · Drug: Placebo

• Active comparator
  VX-787 600 mg BID + Oseltamivir Placebo BID

  Subjects will receive 10 doses of VX-787 600 mg (2\*300 mg tablets) along with matching placebo of Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days.

  Drug: VX-787 600 mg · Drug: Placebo

• Active comparator
  VX-787 600 mg BID + Oseltamivir 75 mg BID

  Subjects will receive 10 doses of VX-787 600 mg tablets (2\*300 mg tablets) along with 75 mg Oseltamivir capsule twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days.

  Drug: VX-787 600 mg · Drug: Oseltamivir 75 mg

Interventions

• DrugVX-787 300 mg

  A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days.

  Also known as: JNJ-63623872

• DrugVX-787 600 mg

  A oral dose of VX-787 600 mg (formulated as 2\*300 mg tablets) will be administered over 5-6 days.

  Also known as: JNJ-63623872

• DrugOseltamivir 75 mg

  A oral dose of 75 mg Oseltamivir capsule will be administered over 5-6 days.

• DrugPlacebo

  Subjects will receive matching placebo of Oseltamivir

Primary outcomes

1. Area under the curve (AUC) of the log10 Nasal Viral Load on Day 8

   Area under the curve (AUC) of the log10 nasal viral load is measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR).

   Time frame: Day 8

Secondary outcomes

1. Time to Resolution of Influenza Symptoms After Initiation of Study Drug

   Estimated acceleration factors expressed as the ratio of the time to resolution of influenza symptoms as compared to placebo time to negativity. Resolution of influenza symptoms was the time of the first of 3 evaluations (over 24 hours) in which all symptom scores for each of the 3 assessments are 0 or 1 for all 7 primary influenza symptoms (cough, sore throat, headache, nasal stuffiness, feverishness or chills, muscle or joint pain, and fatigue) of the Flu-iiQ\^TM. The Flu-iiQ\^TM questionnaire consists of 4 modules, including 1 module assessing influenza symptoms, 1 module assessing the impact of influenza on normal functioning, and 2 modules assessing the impact of influenza on the subject's emotional state. The Influenza Symptom assessment (Module 1) is scored on a 4 point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe) for each of 10 influenza symptoms.

   Time frame: Baseline up to Day 14

2. Safety and tolerability based on assessment of adverse events, clinical laboratory assessments, 12-lead electrocardiograms (ECGs), and vital signs

   Time frame: Day 14

3. Antiviral effect and viral kinetics composite

   Antiviral effect and viral kinetics in relation to: * Duration of viral shedding in nasal secretions by qRT-PCR and viral culture * AUC of the log10 viral load measured by viral culture * Peak viral shedding titer by qRT-PCR and viral culture.

   Time frame: Days 1 - 8

4. Clinical composite symptom scores

   Clinical symptom scores * Composite symptom score AUC * Time to peak of composite symptom score, * Duration and time to resolution of composite symptom score from peak

   Time frame: Day 14

5. Pharmacokinetic parameters of VX787, as determined by population analysis

   A population Pharmacokinetic Pharmacodynamic analysis of plasma concentration data of VX-787 will be performed using the nonlinear mixed effects modeling approach.

   Time frame: Day 14

6. Viral sequence analysis to monitor for emergence of viral variants resistant to VX 787 and to oseltamivir

   Time frame: Day 14

Publications

• Finberg RW, Lanno R, Anderson D, Fleischhackl R, van Duijnhoven W, Kauffman RS, Kosoglou T, Vingerhoets J, Leopold L. Phase 2b Study of Pimodivir (JNJ-63623872) as Monotherapy or in Combination With Oseltamivir for Treatment of Acute Uncomplicated Seasonal Influenza A: TOPAZ Trial. J Infect Dis. 2019 Mar 15;219(7):1026-1034. doi: 10.1093/infdis/jiy547. PubMed 30428049 ↗